BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 18477759 · Received January 9, 2024

    Report

    Report Number
    3012236936-2024-00067
    Event Type
    Malfunction
    Date Received
    January 9, 2024
    Date of Event
    December 21, 2023
    Report Date
    April 1, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474531697
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D9: DEVICE AVAILABLE FOR EVALUATION: YES DATE RETURNED TO MANUFACTURER: 25 JAN 2024 SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: PRODUCT EVALUATION WAS PERFORMED UNDER MAGNIFICATION. THE LENS WAS RECEIVED IN THE ORIGINAL DAISY WHEEL COATED IN VISCOELASTIC AND FOLDED. LOOSE IN THE LENS CASE WAS A YELLOW PARTICLE AND THE HAPTIC COULD BE OBSERVED TO HAVE A YELLOWISH SPOT. THE LENS AND PARTICLE WERE FORWARDED TO EAG LABORATORIES FOR MATERIAL ANALYSIS. WHEN THE LENS WAS RECEIVED AT EAG LABORATORIES THE SPOT ON THE HAPTIC COULD NOT BE FOUND. THE LENS WAS RETURNED TO THE INVESTIGATION SITE AND NO SPOT WAS OBSERVED ON THE HAPTIC. PER EAG LABORATORIES, THE PARTICLE WAS CONSISTENT WITH A MIXTURE OF AN ACRYLIC OR ACRYLIC COPOLYMER AND A VINYL POLYMER SIMILAR TO POLYVINYL PYRROLIDONE. THE PARTICLE FTIR RESULTS WERE COMPARED AGAINST THE MANUFACTURING PROCESS FTIR LIBRARY AND DID NOT YIELD ANY RESULTS WITH AT LEAST A 0.90000 CORRELATION THRESHOLD INDICATING THE PARTICLE WAS NOT CHEMICALLY COMPATIBLE WITH THE PRODUCTS/MATERIALS USED IN THE J&J LENS MANUFACTURING CHAIN. PER VISUAL INSPECTION, THE PARTICLE SHARES CHARACTERISTICS WITH AN INTRAOCULAR LENS WHICH HAS DIFFRACTIVE OPTICAL PROFILE AND COULD BE COMPATIBLE WITH BLUE/VIOLET LIGHT FILTERING MULTIFOCAL LENS. THE PARTICLE WAS PHYSICALLY COMPARED TO A J&J OPTIBLUE LENS. THE PARTICLE HAD A DIFFERENT COLOR THAN THE J&J OPTIBLUE LENS. THE PARTICLE FTIR RESULTS WERE COMPARED TO AN FTIR OF A J&J OPTIBLUE LENS AND RESULTS DID NOT PASS THE 0.9 CORRELATION THRESHOLD, THIS ANALYSIS CONFIRMS THAT THE PARTICLE IS NOT THE JOHNSON AND JOHNSON (J&J) OPTIBLUE LENS MATERIAL. THE COMPLAINT ISSUE OF FOREIGN MATERIAL - LOOSE WAS IDENTIFIED DURING PRODUCT EVALUATION; HOWEVER, BASED ON THE COMPLAINT INVESTIGATION RESULTS THE COMPLAINT ISSUE COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. MANUFACTURING RECORD EVALUATION: BASED ON THE MANUFACTURING RECORDS REVIEW, AND HISTORICAL COMPLAINT REVIEW, THERE IS NO INDICATION OF A PRODUCT MALFUNCTION OR PRODUCT QUALITY DEFICIENCY. THE MANUFACTURING RECORDS REVIEW FOR THIS PRODUCTION ORDER (PO) SHOWS THAT THE UNITS WERE RELEASED WITHIN SPECIFICATION. NO NC/ER WAS FOUND AS PART OF THIS MANUFACTURING RECORDS REVIEW. FOR COMPLAINT HISTORY REVIEW, A SEARCH OF COMPLAINTS RELATED TO THIS PRODUCTION ORDER (PO) WAS PERFORMED IN THE SYSTEM. THE SEARCH REVEALED THAT NO OTHER COMPLAINTS WERE RECEIVED FOR THIS PO. NO NONCONFORMITY REPORT, DOCUMENTATION OR LABELING CHANGES, AND ESCALATIONS ARE REQUIRED. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A2, A4 AND A5: UNKNOWN/ NOT PROVIDED. PATIENT INFORMATION CANNOT BE PROVIDED DUE TO PERSONAL DATA PRIVACY LEGISLATION/POLICY SECTION D6A: IMPLANT DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED IN THE INITIAL SURGERY. SECTION D6B: EXPLANT DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED IN THE INITIAL SURGERY. SECTION E1: EMAIL ADDRESS: UNKNOWN/NOT PROVIDED. SECTION E1: TELEPHONE NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. SECTION H3-OTHER (81): IT WAS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED INTO THE PATIENT'S EYE, THE SURGEON FOUND YELLOW MATERIAL IN THE EYE. BOTH THE IOL AND FOREIGN MATERIAL WAS REMOVED AND A NEW IOL WAS USED TO COMPLETE THE SURGERY. NO ADVERSE EVENT TO THE PATIENT. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597506 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. ZCB00 05050474531697

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown